AXONA® DELIVERS SIGNIFICANT IMPROVEMENTS IN COGNITIVE FUNCTION

Clinical studies in Alzheimer’s disease1

Axona was evaluated in a double-blind, randomized, placebo-controlled study performed at multiple US clinical centers in a population of 152 patients with probable mild to moderate Alzheimer’s disease.

Patients were allowed in the trial if they were on current AD medications, provided that they had been on stable dosing for at least 3 months. Approximately, 80% of the patients in the trial were on one or more approved AD medications.

Proven cognitive results demonstrated in clinical studies2

Significant difference between Axona (n = 77) and placebo (n = 63) groups in change from baseline in total ADAS-Cog† scores at day 45 (P = 0.024)

  • A 4.77-point difference was observed in change from baseline ADAS-Cog scores among ApoE4(-) patients receiving Axona vs. placebo at day 45 (P = 0.0005)
  • A 6.26-point difference was observed in change from baseline ADAS-Cog scores between Axona vs. placebo dosage-compliant‡ ApoE4(-) patients at day 45 (P = 0.001)

Cognitive benefits maintained over time2

AD patients taking Axona maintained a slight improvement from baseline after 90 days of daily administration, whereas the placebo group still demonstrated a decline (P = 0.0767)§

  • A 3.36-point difference was observed in change from baseline ADAS-Cog scores among ApoE4(-) patients receiving Axona vs. placebo at day 90 (P = 0.015)
  • A 5.33-point difference was observed in change from baseline ADAS-Cog scores between Axona vs. placebo dosage-compliant ApoE4(-) patients at day 90 (P = 0.006)

 

References: 1. Axona, [Prescribing Information]. Broomfield, CO: Accera, Inc.; September 2009. 2. Henderson ST, Vogel JL, Barr LJ, et al. Study of the ketogenic agent AC-1202 in mild to moderate Alzheimer’s disease: a randomized, double-blind, placebo-controlled, multicenter trial. Nutr Metab (Lond). 2009;6:31.

† ADAS-Cog, Alzheimer’s Disease Assessment Scale—Cognitive subscale.

‡ Dosage-compliant subjects were defined as those who reported consuming a total cumulative dose of at least 80% of the total intended dose.

§ P = 0.0767; the difference between groups was not statistically significant at 90 days.